FDAnews
www.fdanews.com/articles/179867-fda-postpones-pdufa-for-roches-ms-therapy-ocrevus-to-march

FDA Postpones PDUFA for Roche’s MS Therapy Ocrevus to March

December 30, 2016

The FDA has extended the PDUFA date for Roche’s multiple sclerosis candidate Ocrevus to March in order to review new manufacturing data submitted by the company.

The manufacturing data will require additional time for FDA review, the company said. The extension is not related to the efficacy or safety of Ocrevus.

Roche evaluated the safety and efficacy profile of Ocrevus in randomized, double-blind, double-Phase III trials.

View today's stories